Biologically active phospholipid-comprising complex for treatment of psoriasis and chronic prostatitis

FIELD: medicine.

SUBSTANCE: invention proposes the biologically active complex comprising phospholipids and the following biologically active substances - fatty acids, serines, peptides, amino acids, vitamins trace elements and extraction from cattle testicles prepared by successive fractionation with carbon dioxide and ethyl alcohol. The complex provides expanding spectrum of medicinal agents used in dermatological and urological practice and improving quality of the preparation. Invention can be used in treatment of psoriasis, prostatitis caused by prostatitis of sexual disorders.

EFFECT: valuable medicinal properties of complex.

2 tbl

 

The invention relates to medicine and can be used for the treatment of psoriasis, prostatitis and is caused by prostatitis sexual disorders.

A known number of integrated medicines containing phospholipids as the main active substance together with the other ingredients of plant, animal, or obtained by chemical means.

These drugs include Lipotherm, LIPOSTABIL, Aminophosphate (1), and Lipofundin (2), Intralipid (3), table 4).

Common to all these products is the presence of phospholipids as main active substance. The presence of phospholipids determines the main direction of action of drug - regulation of intracellular processes at the level of membranes. Functional significance of phospholipids based on their biphasic nature that allows you to adjust the permeability of the lipid layer of biological membranes, to restore its physico-chemical properties and to create adequate conditions for the functioning of enzymes. Phospholipids have antioxidant properties.

As a prototype of the selected remedy Essentiale produced in Germany. Essentiale (Esseutiale) are produced in two dosage forms : injection solution and capsules. The product contains about 70% of natural phospholipids (the source not specified) in the form diglycerin esters holinesterzoy acid, extract from soybean seeds with a high content of unsaturated fatty acids and added features such as tallow, soybean oil, hydrogenated, Kastoria oil, ethanol, ethylvanillin, 4-methoxyacetophenone, gelatin, dye E 171, E 172, DL-a-tocopherol. Indications for use Essentiale are chronic diseases of the liver, fatty degeneration and hepatic toxicity, psoriasis, radiation syndrome.

The aim of the invention is the expansion of the range of medicines in dermatological and urological practice, improving the quality of the drug.

The invention consists in using a new integrated product containing phospholipids and such biologically active components - fatty acids, sterols, peptides, amino acids, vitamins, microelements for the treatment of psoriasis, prostatitis and is caused by prostatitis sexual disorders in men. Listed all complex substances in the composition of the drug called Stimutacs presents natural biologically active substances isolated from bovine testis. The tissue of the testes of cattle, purified from dietary lipids by extraction with carbon dioxide, extracted with a solution of ethyl alcohol. Alcohol extract was separated by centrifugation. Centrifugal evaporated.

The complex contains the inhabitants of natural biologically active substances in the following quantities (mass.% of dry matter):

phospholipids56,5±4,0
other lipids17,2±2,5
including free higher fatty
acids and sterols
nitrogen-containing substances, including20,0±4,0
peptides and amino acids
vitamins, micro and macro-elements6,3

The complex of biologically active substances in the composition of the preparation, it provides high efficiency, because the effect of phospholipids combined and supplemented by the action of low molecular weight peptides, which play the role of bioregulators. Fatty acids, particularly arachidonic, linoleic are biogenic precursors of prostaglandins involved in the regulation of cellular metabolism and affect the circulation, including circulation.

Amino acids that are part of the complex, stimulate metabolic processes, as the plastic material for the synthesis of protein, and vitamins and minerals to enhance the antioxidant properties of phospholipids and enzymes. The synergy of the components of a comprehensive drug Stimutacs determines the high efficiency of its actions.

P is Torinese number of diseases has been a violation of lipid metabolism, in these cases used for the treatment of drugs normalize this process, including preparations containing phospholipids. So taken as a prototype Essentiale successfully used for the treatment of psoriasis. The course of complex treatment with this drug is not less than 3 months. Essentiale is used in two dosage forms. The solution for injection is administered 2-4 capsules per day for 10 days, the contents of the ampoule is diluted by the blood of the patient in the ratio of 1:1. Before intravenous infusion of Essentiale prescribed a two-week course of treatment by taking 2 capsules 3 times a day, and after intravenous infusion to continue taking the capsules for 2 months. The cost of a course of drug treatment is high, and therefore its use in hospitals is very limited. The positive effect of drugs containing phospholipids indicated in the treatment of prostatitis. Lipids, neutral fats, phospholipids and cholesterol are an important component of the prostate gland secretion. The main part of the phospholipids - phosphatidylcholine (lecithin) is a permanent component of the cellular structure of membranes defining their permeability. A large number of lecithin seeds in the prostate fluid is an indicator of its healthy condition (6).

Based on these data, was conducted clinical testing of a new pre is Arata Stimutacs two clinics - Nizhny Novgorod research dermatovenerologic Institute in the Department of chronic dermatoses and in the regional hospital. N. A. Semashko. For clinical study was prepared two dosage forms of the drug - suppositories and lyophilized powder. Suppositories were prepared on the basis of Witepsol N-15 and W-35 conventional for the manufacture of this drug form technology. The weight of the suppository was 2 g, and the content in suppositories active ingredient equal to (150±10) mg For the preparation of freeze-dried form Stimutacs was suspensible in water to a concentration (600±50) mg %, the suspension was poured into vials of 10 and 25 cm3and subjected to freeze drying uniform heat on the shelves of the freeze installation 5°per hour at a pressure of 0.03 Top and condenser temperature of minus 50±2)°C. the Duration of drying was equal 22-26 hours, the residual moisture of the product is not exceeded (3,0±0,5)%.

The essential difference between the comprehensive drug Stimutacs from the prototype is the following:

1) presents complex of biologically active components extracted from natural raw materials of the original method;

2) with the exception of phospholipids all other ingredients not repeat composition Essentiale;

3) Stimutacs used in other l the drug forms - suppositories and lyophilized powder.

The advantage of the prototype is as follows:

1) dosage form of the drug in the form of suppositories promotes rapid release of drug substances from the basics. Due to the high suction capacity of the mucosa of the rectum quickly achieved a high concentration of drug in the blood. Due to the deposition of the barrier function of the liver increases the duration of circulation of medicinal substances in the blood line;

2) suppozitornyj form allows you to eliminate the disadvantages of injecting drug - route of administration is painless and does not require skilled health personnel;

3) there is no possibility of infection of the patient;

4) the absence of drug chemical substances, fillers, colorants, stabilizers;

5) balanced complex of natural substances, providing the synergy of their actions, selected from the same source of raw materials - bovine testis;

6) availability of the drug due to its lower cost and domestic production;

and, as follows from the below data, clinical trials,

7) indications for use for prostatitis, missing in the testimony for the prototype;

8) a shorter course of treatment.

Before conducting the testing Nor gorodski Institute of hygiene and occupational pathology was conducted expert evaluation of the toxicity of a new drug. Experimental Toxicological studies have shown that the drug indicators of acute toxicity, cumulation coefficient, irritating, sensitizing and obscherezorbtivnymi action complies with the safety requirements to pharmacological agents.

The effectiveness of Stimutacs in the treatment of patients with psoriasis was conducted in the Department of chronic dermatoses, NIKWI. The group of patients consisted of 5 women and 7 men aged from 18 to 47 years. All patients had widespread psoriasis in the acute stage of the process. Stimutacs applied rectally in suppository 1 time a day for 15-30 days. Before and after treatment the study was conducted General blood analysis, urine analysis, serum transaminase, lipid, phospholipid spectrum of serum and erythrocyte membranes.

Table 1.

A list of patients receiving Stimutacs
No.NAME of the patientno history of the disease
1Simon's NV2121
2Kudaev SF2108
3Pastukhov, H.E.70
4Timachev VA107
5 Zaitseva NM683
6O.V. Kukushkin706
7Strelnikov AV762
8Mishina E.V.782
9Telushkin L.A.767
10Shepilov CENTURIES875
11Chestnut A.I.940
12Leontiev CENTURIES163

All patients tolerated the drug Stimutacs well. Complications and side effects have been recorded. All patients with psoriasis treated with Stimutacs, after 7-10 days showed a significant improvement in the clinical picture of the disease in the form of stopping peeling, reducing the brightness of the rash and reduce air infiltration in homes. In 6 patients the previous exacerbation of psoriasis were stopped only by the use of cytotoxic drugs (methotrexate), with severe adverse side effects. Using Stimutacs in this group of patients has allowed to achieve remission without the use of methotrexate.

In the process of therapy Climatecam not been adverse shifts from General blood analysis, urine analysis, serum transaminase. In the study of lipid metabolism has been shown that Stimate is not substantially affect the level of serum cholesterol. Under the influence of Stimutacs normalization of the levels of total lipids and triglycerides. As is known, the biochemical composition of cell membranes reflects the cell metabolism in General, and therefore its functioning. In the study of phospholipid spectrum and lipid peroxidation of erythrocyte membranes in patients with psoriasis before treatment revealed an increase in the fraction of phosphatidylcholine (PC) and phosphatidylethanolamine (pea), as well as the decrease in the effective absorption with added LFH), indicating a violation of the permeability of erythrocyte membranes. After treatment with Climatecam there was a positive dynamics of these indicators. In the clinical study Stimutacs was recommended as a promising drug in the treatment of psoriasis, Stimutacs along with a high efficiency has good tolerability and safety.

Clinical testing of Stimutacs in the urology Department of the hospital. N. A. Semashko was preceded by the testing of patients by R. Voll.

Examination of patients and testing of the drug was carried out on hardware - software complex "IMEDIS-Voll" production company "IMEDIS". Testing was subjected to two dosage forms of the drug - suppositories and dried powder of Stimutacs. The method of testing was as follows: in the circuit device-PA is ient through the passive electrode is included, the test drug. Were used for testing BAHT (biologically active points) of those meridians that correspond to the intended pharmacological spectrum of action of the studied drugs.

By R. Voll surveyed and conducted medical testing 14 patients in four age groups:

30-40 years 3 persons;

40-50 years 3 persons;

50-60 years - 6 people;

60 years - 2 people.

Among patients identified 3 groups:

1. congestive and inflammatory diseases of prostate - 6 people,

2. prostate adenoma is 2 people,

3. without organic pathology to 6 people.

Studies were conducted on the following BATH:

1. The hypothalamus (evaluation of the effect of acute and chronic toxicity, psycho pathology and radicular cysts).

2. The pineal gland, the pituitary gland (indirect assessment antigonadotropic functions epiphysis and gonadotropic functions of the pituitary gland).

3. The sex glands, the adrenal glands.

4. The prostate gland, seminal tubercle, seminal vesicles, penis.

5. The epididymis, seminal cord.

Study above the BATH is allowed to determine the influence of drugs at all levels of the pathogenesis of the disease.

According to the test results it was possible to conclude that the effect of the tested dosage forms should be most pronounced at the following ur is vnah:

The hypothalamus, pituitary gland, sex glands, adrenal glands, prostate, epididymis.

Stimutacs in the tested formulations was effective in almost all age categories, but its effect was most pronounced in the age group of 50-60 years. According to the results of the conducted research it was possible to predict the next action of the investigational medicinal forms of drug:

1. Regulation of inflammatory and degenerative processes in the prostate gland.

2. Stimulation of gonadal function at the hypofunction.

3. Stimulation of spermatogenesis.

4. Braking congestive and inflammatory processes.

5. Resolving action on connective tissue, including benign tumors, scar changes and patterns.

6. improving hemodynamics genitals.

These studies served as the basis for conducting clinical trials of the drug in the group of patients with chronic prostatitis.

The group of patients consisted of 16 men aged 19 to 50 years old.

Stimutacs applied rectally in suppositories once a day for two weeks to one month.

The control group received standard therapy - Fipronil in suppositories.

Two patients with chronic prostatitis were combined with benign prostatic hyperplasia stage 1, the two pain who's was complicated urethritis. In 10 patients history moved STIs (chlamydia, ureaplasmosis, garderella), one patient removed the right kidney, chronic cystitis.

All the patients before treatment was examined: ultrasound of the prostate, the analysis of prostatic juice, swabs from the urethra. Before treatment and during treatment at the Department of functional diagnostics were conducted drug testing by R. Voll.

In the process of treatment in 15 of 16 patients reported a subjective and objective improvement. The positive dynamics was noted in the reduction or cessation of pain, the disappearance of a sense of burning in the urethra, reducing the frequency of urination, improve erection, increase sexual potency, the disappearance of pain during coitus. Compared with the control group, when use of the drug Stimutacs positive dynamics was noted in the earlier period - the fourth or fifth day of application instead of 10 days with standard therapy. Significantly reduced the terms of relief of symptoms of chronic cystitis. Persistent improvement occurred in the 14-30 day depending on the severity of the disease. A list of patients receiving Stimutacs.

td align="center"> no history of the disease
Table 2
№ p/pSurname ACTING sickAge
1Klegin I.N.50 years107101
2Pershin A.M.37 years106814
3Kiselev DU32342 outpatient map
4Shcherbakov A.I220118133
5Kargapoltsev SV29100501
6Smirnov, G.41101277
7Nurutdinov AS46 years106949
8Uryadov P.E.24108721
9Dubinin, J.V.40 years114044
10Bychkov, VA49100815
11Vorontsov AA29114497
12Ushakov PV19115083
13Afanasiev S.V.28 years100661
14Plovers Yu,P.46 years5071
15Kitaev, VA24outpatient map
Martynov O.A.27 years11463

All patients tolerated the drug well, allergies, complications and side effects have not been recorded.

As a result of testing Stimutacs recommended as a promising drug for the treatment of prostatitis.

Sources of information

1. Whisper, Humorously. Bulletin of the Academy of medical Sciences of the USSR, No. 6, 1990, p.19-27.

2. Medmaravis. Medicines, M., 1986, Vol.2.

3. A 61 K 9/14, 31/557 US 6251436 B1.

4. A 61 K 31/685 FR 2556050 A1.

5. A 61 K 35/12, 35/30, 35/48, 35/50 EN 2192871 C2.

6. Nperson. Metabolic aspects in dermatology, Sat. scient. works KVI, Bitter, 1984, pp.96-99.

Biologically active complex for the treatment of psoriasis and chronic prostatitis, characterized by the fact that he extracted from the testes of cattle sequential fractionation of carbon dioxide and ethyl alcohol, and includes phospholipids in the number of 56.5±4,0%free higher fatty acids and sterols in the number 17,2±2,5%, peptides and amino acids in the amount of 20.0±4,0%, as well as vitamins, macro - and microelements in the amount of 6.3%.



 

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